Depo-Medrol on Psoas After LLIF

Effect of Depo-Medrol Application on the Psoas Muscle After Transpsoas LLIF on Post-operative Hip Flexor Weakness, Thigh Pain and Numbness

The goal of this study is to determine the effects of a corticosteroid administered to the psoas muscle following a transpsoas lateral lumbar interbody fusion (LLIF) on postoperative hip flexor weakness and thigh pain and numbness.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Muscle Weakness; Paresthesia; Pain, Muscle
• Intervention / Treatment: Drug: Gel-Flow NT; Drug: Depo-Medrol

Detailed Description

Primary Objective and Outcome Measure:

• Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.

Secondary Objectives and Outcome Measures:

• Quantify the difference in rates and severity of postoperative hip flexor weakness, and numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.

• Quantity patient reported outcomes measures (PROMs) (EQ5D, ODI, and sciatica Bothersome index between those that did and did not receive a depo-medrol injection. Specifically:

  • EQ5D: Eur-Quality of Life 5 dimension questionnaire
  • ODI: Oswestry Disability Index
• Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection.

Ancillary Objectives and Outcome Measures:

• To determine the effect of clinically relevant covariates including sociodemographic and comorbidities on the course of postoperative pain and associated outcome measures and whether the effect of these covariates moderate the effect of postoperative pain.

Groups:

• Control group (standard care) - 1cc gel foam powder mixed with thrombin
• Steroid group (standard care + study intervention) - 1cc gel foam powder mixed with thrombin and 80mg depomedrol

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hardeep Singh, MD; Phone Number: 860-679-6883; Email: uconnorthopaedics@uchc.edu
• Study Contact Backup: Name: Study Coordinator; Phone Number: 860-679-6883; Email: uconnorthopaedics@uchc.edu

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • Recruiting
      • UConn Health
      • Contact: Study Coordinator; Email: uconnorthopaedics@uchc.edu
      • Principal Investigator: Hardeep Singh, M.D.
      • Sub-Investigator: Isaac Moss, M.D., C.M., M.A.Sc., FRCSC
      • Sub-Investigator: Scott Mallozzi, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients from the practices of Drs. Singh, Mallozzi, Moss
• Transpsoas (PTP or LTP) lateral lumbar interbody fusion (LLIF) 1-3 disc levels with posterior instrumentation (Open or MIS) with or without laminectomy, must include L3-4 and/or L4-5
• Patients who agree to be a part of the study
• Patients with lumbar disc degeneration
• Patients between ages of 18 and 75

Exclusion Criteria:

• Scoliosis >10°
• Spondylolisthesis >Grade 1
• Flatback deformity
• Patients with insulin dependent diabetes
• Patients with >3 levels of fusion
• Alternative interbodies
• Chronic oral steroid users
• Patients with allergy/intolerance to depo-medrol or other steroids
• Patients requiring bilateral transpsoas approaches
• Patients with ipsilateral symptomatic hip pathology
• Revision fusion procedures
• Cases involving trauma, tumor, or infection
• Patient's not capable of providing consent themselves
• Non-fluent English speakers (for consenting reasons)
• Patients who are lost to follow-up before the two year follow up period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group (standard care); 1 cc gel foam powder mixed with thrombin	Drug: Gel-Flow NT; hemostatic agent
Experimental: Test group (standard care + study intervention); 1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol	Drug: Gel-Flow NT; hemostatic agent; Drug: Depo-Medrol; steroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.	Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from "no pain" to "worst pain imaginable"?	2-3 weeks following surgery
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.	Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from "no pain" to "worst pain imaginable"?	6 weeks following surgery
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.	Visual Analog Scale (VAS) - Anterior Thigh Pain How would you evaluate the pain you are feeling today at the front of your thigh on a scale from "no pain" to "worst pain imaginable"?	12 weeks following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantify the difference in rates of postoperative thigh numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.	Thigh numbness - binary: yes/no	6 months, 1 year, 2 years
Quantify the difference in severity of postoperative hip flexor weakness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.	Hip flexion strength measured via graded exam: the Medical Research Council Manual Muscle Testing scale. This method involves testing key muscles from the lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: 0 No muscle activation; Trace muscle activation, such as a twitch, without achieving full range of motion; Muscle activation with gravity eliminated, achieving full range of motion; Muscle activation against gravity, full range of motion; Muscle activation against some resistance, full range of motion; Muscle activation against examiner's full resistance, full range of motion	6 months, 1 year, 2 years
Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Euro-Quality of Life 5 dimension questionnaire (EQ5D)	The Euro-Quality of Life 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems."	2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Oswestry Disability Index (ODI)	The Oswestry Disability Index (ODI) is an outcome measure that was designed to assess function in activities of daily living for those with acute or chronic back pain. The ODI consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).	2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
Quantity patient reported outcomes measures (PROMs) between those that did and did not receive a depo-medrol injection: Sciatica Bothersomeness Index	Sciatica Bothersomeness index includes self-reported ratings of symptom intensity of: Leg pain; Numbness or tingling in the leg, foot or groin; Weakness in the leg/foot; Back or leg pain while sitting Each symptom item is rated on a scale from 0 to 6, with 0 being not bothersome, 3 somewhat bothersome and 6 extremely bothersome.	2-3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years
Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection.	Fusion rate - Assessed with Flexion, Extension X-ray (screw loosening/fracture, instability) CT Scan if patient has a symptomatic (pain) pseudoarthrosis (lack of fusion)	1 year and 2 years

Collaborators and Investigators

• Sponsor: Hardeep Singh
• Collaborators: Society for Minimally Invasive Spine Surgery
• Investigators: Principal Investigator: Hardeep Singh, M.D., UConn Health

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: lumbar spine; corticosteroid; Depo-Medrol; lateral lumbar interbody fusion; psoas muscle; LLIF; postoperative hip flexor weakness; postoperative thigh pain; postoperative thigh numbness
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Postoperative Complications; Pathologic Processes; Neuromuscular Diseases; Sensation Disorders; Musculoskeletal Pain; Somatosensory Disorders; Pain, Postoperative; Muscle Weakness; Asthenia; Myalgia; Paresthesia; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Neuroprotective Agents; Methylprednisolone Acetate; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 23-090-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No